Company Description

LVD Biotech - iVascular Group is an international medical technology group specializing in the development, manufacturing, marketing and distribution of innovative medical devices for the treatment of vascular diseases worldwide. Our vertically integrated business model enables us to manage the entire product lifecycle, from innovation and development to manufacturing and commercialization.

The Group comprises two highly specialized and complementary companies:

- LVD Biotech, our innovation center, leads and drives research and development of new technologies, managing the entire product development cycle from the initial concept through to the preparation of regulatory dossiers. This includes generating, developing and protecting knowledge through intellectual property.
- iVascular transforms this innovation into medical solutions that reach healthcare professionals and patients through the manufacturing, logistics, marketing and international commercialization of a portfolio of medical devices across the Coronary, Peripheral and Neurovascular fields.

With a team of more than 600 professionals and a commercial presence in over 86 countries, both companies work closely together in an environment of continuous collaboration, combining science, innovation, industrial excellence and the highest quality standards.

Together, we drive the development of cutting-edge medical solutions with a shared goal: improving patients’ quality of life worldwide.

Position

YOUR MISSION:

Ensure that manufactured products comply with the quality requirements and specifications established by the company and applicable regulations before being released to the market. Ensure that product issues arising during production are managed swiftly, comprehensively and thoroughly, according to their level of risk. Ensure the robustness of processes, products and preventive measures in order to supply defect-free products.

DUTIES AND RESPONSIBILITIES:

To achieve this, you will evaluate, develop and implement preventive quality measures, in-process controls,



and initiatives to improve the robustness of processes and raw materials. As a key part of your role, you will also monitor and analyse production and field issues and data to identify and resolve problems as quickly and effectively as possible.

Product Quality Issue Management

- Ensure that nonconformities are managed in accordance with established requirements.
- Identify how issues should be grouped and prioritised in order to focus resources.
- Lead investigations or collaborate with the Technical Department and Operations. Ensure that the root cause is identified and that issues do not recur.
- Propose, support and agree on the disposition of materials and semi-finished products in a swift and effective manner. Perform follow-up and trend analyses and propose CAPAs.
- Support the investigation of customer complaints.

Risk Analysis

- Ensure that process FMEAs are carried out effectively.
- Participate in product risk analyses.
- Perform risk analyses for nonconformities.
- Participate in design reviews.

Product Quality Plans

- Ensure that product quality plans are satisfactorily implemented, including process and raw-material parameters and quality attributes.
- Participate in product transfers and product changes. Participate in process changes and ensure that the relevant deadlines are met.

Materials and Suppliers

- Assess and follow up on raw-material nonconformities together with Quality Control.
- Analyse the supplier’s response.
- Participate in supplier audits.

Equipment and Processes

- Review and approve equipment qualifications and process and software validations.
- Propose new manufacturing or inspection equipment and tooling.




- Support the drafting of manufacturing instructions to ensure that they properly capture the necessary steps, controls and verification elements.

Quality Management System

- Help ensure that the Quality Management System has been effectively implemented in the production area, particularly with regard to document control, training plans, nonconformities, change controls, GMPs, validation and transfer, the traceability of materials and products, and data integrity.
- Support the definition of quality objectives and indicators, the performance of internal audits and process inspections, and quality assurance activities.
- Support the identification of Quality Management System requirements to ensure compliance with the regulatory requirements of the jurisdictions in which the products are intended to be marketed.

Requirements

DESIRED PROFILE:

Academic Qualifications:

Bachelor’s degree or equivalent qualification in Engineering or another related discipline.

Training in ISO 13485, MDR, MDSAP and 21 CFR.

Experience:

At least eight years of experience in a similar position.

Skills and Attributes:

Analytical, proactive, solution-oriented, meticulous and organised.

Strong communication and interpersonal skills.

Benefits

Health Insurance Flexible working hours On-the-job training Language courses Career progression opportunities Staff canteen Free On-Site Gym

Other information

WHAT WE OFFER

- Permanent and stable contract in a project with high global impact and expanding internationally.
- Professional and personal development in a vibrant, dynamic, and youthful environment.
- Competitive salary tailored to your experience, along with an attractive benefits package.
- Adaptable working hours to support a healthy work-life balance.
- Flexible compensation (meal vouchers, transportation, and childcare assistance).
- Access to our iWellness program: gym and physiotherapist on site.
- Corporate events and gifts.
- Subsidized on-site company cafeteria.

Apply for this job

📌 Senior Quality Engineer (España)
🏢 iVascular
📍 España